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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001918-15 | EudraCT Number |
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This study has been cancelled before initiation due to company's prioritisation decisions linked to resources restrictions.
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The purpose of this study is to assess the long-term persistence of immunity to hepatitis A in adults who were vaccinated 21-25 years earlier with hepatitis A vaccine, Havrix®.
This is a long-term persistence study in which subjects who participated in the primary studies HAV-112 (208109/108) or HAV-123 (208109/114) and did not receive an additional dose of hepatitis A vaccine since then, will be invited to provide a blood sample at Years 21 to 25 after their second vaccine dose. No vaccine will be administered during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAV Group | Experimental | Subjects who were previously vaccinated with Havrix in primary studies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | At Years 21 to 25 after their second vaccine dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity with respect to components of the study vaccine in terms of anti-HAV seropositivity status and GMCs. | 21 to 25 years after the second vaccine dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of serious adverse events (SAEs). | During the entire study period (Year 21 to Year 25). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Wilrijk | 2610 | Belgium |
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| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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